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Clinical Trials: A Potential Growth
Engine For Greece
Key Considerations To Attract Clinical Trial
Investment
Jim Sage
President PhRMA Innovative Forum (PIF)
President and Managing Director, Pfizer Hellas
Innovation Forum Greece
Who is the PhRMA Innovation Forum (PIF)
20 world leading R&D pharma companies
Pharmaceutical innovation is a good investment for Greece
Pharmaceutical innovation
contributes to better health
Innovation Forum Greece
Mean age at death, Greece,
1995-2010
Pharmaceutical innovation increased longevity in
Greece by 0.87 years during the period 1995-2010
Per capita expenditure on cardiovascular
hospitalizations would have been $89 (70%) higher in
2003 had new cardiovascular medicines not been
introduced in the period 1995–2003.2
$24
-$89-$100
-$80
-$60
-$40
-$20
$0
$20
$40
Cost of New
Medicines
Hospitalization
$perCapita
Medicines use yields savings in the
HC system
4www.efpia.eu
Medicine use yields
Significant health gains and savings in other parts of healthcare systems
The Pharma Industry has a significant impact on the Greek
Economy
Better Health = More Wealth
The Pharma Industry is a key economic
contributor to Greece
Total Impact
total jobs due
to pharma
industry
operations in
Greece
87.400
Total Impact
3.5% of GDP
€6.2b
Pharma employees in Europe generate 80% more value per employee vs other industries
2005-2015 Inflows of FDI in Greece (million Euros) – Bank of Greece 2016
OECD highlights the low performance of Greece
in FDI and recommends actions Only € 0.6b FDI in Greece for 2015
- €5b per year
from Greek
economy
Innovation Forum Greece
Improvement in Foreign Direct Investments (FDI)
is critical for the recovery of Greek economy
4.78 % of GDP
the FDI global average / World Bank
more than € 6 b in Greece before crisis
Pharmaceutical Innovation via Clinical Trials can bring more Foreign
Direct Investment and be a significant growth pillar for Greece
Innovation Forum Greece
€31B was invested in clinical trials
in Europe, Greece is not attracting
its fair share
Source : EFPIA, The Pharmaceutical industry in figures, 2015 report
Pharma has the highest R & D intensity
of any Industry
According to country size, Greece should attract 1.5% of total CT investment in Europe,
which means approx. €400 million more
40 75 77 80 85 85 124 158 161 180 197 197 274 305
642 650 765
953
13501453
2453
4564
4868
5338
5813
0
1000
2000
3000
4000
5000
6000
Croatia
Turkey
ChechRrepublic
Greece
Cyprus
Portugal
Norway
Hungary
Slovenia
Romania
Finland
Russia
Poland
Ireland
Netherlands
Austria
Sweden
Spain
Italy
Denmark
Belgium
France
UK
Switzerland
Germany
Clinical trials investment brings value to the state, medical
community and patients
Innovation Forum Greece
Patients
€31B
Clinical trials
State
+ €100M
• Reputation
• Resources
• Knowledge
• Expertise
Access to the newest
medicines
Physicians4.300 jobs €220Μ
Skilled workforce
Medical
Access of patients
Predictable environment
Clinical trial cost
Clinical trial quality
Time to approval
Tax breaks & Incentives for investment
Adoption of innovation & fair pricing
Public -Private partnership
If Ireland and Belgium can why not Greece? What does it take to
attract Clinical Trials
COMMERCIAL
Innovation Forum Greece
CLINICAL
Unfortunately current conditions in Greece erode the value of
existing investments and limit future ones
No room has been created
for innovation
The tax on during business
has escalated to
unsustainable levels
The Pharma Industry is < 1/2
the size it was 6 years ago
Evolution of pharmaceutical
expenditure 2009-2015
Note: hospital and out-patient spent data are based on annual
budget objectives
*: estimation
0
1,000
2,000
3,000
4,000
5,000
6,000
2009 2010 2011 2012 2013 2014 2015
net public pharma
spending
co-payment*
ESY Hospital Pharma
Million€
Price difference vs EU
average
Innovation Forum Greece
-53,0% -15,6%
53,8%
-60,0%
-40,0%
-20,0%
0,0%
20,0%
40,0%
60,0%
ON Patent OFF
Patent
Generics
193
177
226
310
320
78
153
202
319
410
220
0
50
100
150
200
250
300
350
400
450
2012 2013 2014 2015 2016
€ m. rebates € m. clawback
€ m. Hospital clawback
Claw-back & rebates evolution
IMS Market Analysis , Nov 2015
est.
New Measures will further limit access to innovation and
investment in Greece
A similar new product rebate (1/3 the size) in Cyprus led to 20
products not being launched and the eventual removal of the rebate
Innovation Forum Greece
Area Measure Implication
Reimbursement Criteria 14 Countries/7 HTA Double or triple the time to
launch a product in Greece
New Product Rebate 25% Will Likely prevent most
products from launching in
Greece
Structural Reform None Will ensure rebates/claw backs
remain high and in so doing
threaten existing investment
Re-pricing Maintain price protection for
Generics
Ensure that there continues to
be limited room for innovation
Greece already ranks low in innovation - what’s the right direction
for the future?
Innovation Forum Greece
What we can do to maintain and increase investment in Greece
 Immediate Removal of new measures which harm innovation and limit Foreign
Investment
 A transparent evidence based P&R system that recognizes and rewards
innovation
 A public pharma budget adequate enough to cover patient’s real needs
 Appropriate investment incentives
 Allow clinical trials to be offset against the clawback
 Tax incentives
 Collaborative effort to improve the time required to approve a clinical trial
 Development of a national multi-year plan for pharmaceuticals to contribute to the
economic growth of Greece done via a public-private partnership
Innovation Forum Greece

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  • 1. Clinical Trials: A Potential Growth Engine For Greece Key Considerations To Attract Clinical Trial Investment Jim Sage President PhRMA Innovative Forum (PIF) President and Managing Director, Pfizer Hellas Innovation Forum Greece
  • 2. Who is the PhRMA Innovation Forum (PIF) 20 world leading R&D pharma companies
  • 3. Pharmaceutical innovation is a good investment for Greece Pharmaceutical innovation contributes to better health Innovation Forum Greece Mean age at death, Greece, 1995-2010 Pharmaceutical innovation increased longevity in Greece by 0.87 years during the period 1995-2010 Per capita expenditure on cardiovascular hospitalizations would have been $89 (70%) higher in 2003 had new cardiovascular medicines not been introduced in the period 1995–2003.2 $24 -$89-$100 -$80 -$60 -$40 -$20 $0 $20 $40 Cost of New Medicines Hospitalization $perCapita Medicines use yields savings in the HC system
  • 4. 4www.efpia.eu Medicine use yields Significant health gains and savings in other parts of healthcare systems The Pharma Industry has a significant impact on the Greek Economy Better Health = More Wealth The Pharma Industry is a key economic contributor to Greece Total Impact total jobs due to pharma industry operations in Greece 87.400 Total Impact 3.5% of GDP €6.2b Pharma employees in Europe generate 80% more value per employee vs other industries
  • 5. 2005-2015 Inflows of FDI in Greece (million Euros) – Bank of Greece 2016 OECD highlights the low performance of Greece in FDI and recommends actions Only € 0.6b FDI in Greece for 2015 - €5b per year from Greek economy Innovation Forum Greece Improvement in Foreign Direct Investments (FDI) is critical for the recovery of Greek economy 4.78 % of GDP the FDI global average / World Bank more than € 6 b in Greece before crisis
  • 6. Pharmaceutical Innovation via Clinical Trials can bring more Foreign Direct Investment and be a significant growth pillar for Greece Innovation Forum Greece €31B was invested in clinical trials in Europe, Greece is not attracting its fair share Source : EFPIA, The Pharmaceutical industry in figures, 2015 report Pharma has the highest R & D intensity of any Industry According to country size, Greece should attract 1.5% of total CT investment in Europe, which means approx. €400 million more 40 75 77 80 85 85 124 158 161 180 197 197 274 305 642 650 765 953 13501453 2453 4564 4868 5338 5813 0 1000 2000 3000 4000 5000 6000 Croatia Turkey ChechRrepublic Greece Cyprus Portugal Norway Hungary Slovenia Romania Finland Russia Poland Ireland Netherlands Austria Sweden Spain Italy Denmark Belgium France UK Switzerland Germany
  • 7. Clinical trials investment brings value to the state, medical community and patients Innovation Forum Greece Patients €31B Clinical trials State + €100M • Reputation • Resources • Knowledge • Expertise Access to the newest medicines Physicians4.300 jobs €220Μ
  • 8. Skilled workforce Medical Access of patients Predictable environment Clinical trial cost Clinical trial quality Time to approval Tax breaks & Incentives for investment Adoption of innovation & fair pricing Public -Private partnership If Ireland and Belgium can why not Greece? What does it take to attract Clinical Trials COMMERCIAL Innovation Forum Greece CLINICAL
  • 9. Unfortunately current conditions in Greece erode the value of existing investments and limit future ones No room has been created for innovation The tax on during business has escalated to unsustainable levels The Pharma Industry is < 1/2 the size it was 6 years ago Evolution of pharmaceutical expenditure 2009-2015 Note: hospital and out-patient spent data are based on annual budget objectives *: estimation 0 1,000 2,000 3,000 4,000 5,000 6,000 2009 2010 2011 2012 2013 2014 2015 net public pharma spending co-payment* ESY Hospital Pharma Million€ Price difference vs EU average Innovation Forum Greece -53,0% -15,6% 53,8% -60,0% -40,0% -20,0% 0,0% 20,0% 40,0% 60,0% ON Patent OFF Patent Generics 193 177 226 310 320 78 153 202 319 410 220 0 50 100 150 200 250 300 350 400 450 2012 2013 2014 2015 2016 € m. rebates € m. clawback € m. Hospital clawback Claw-back & rebates evolution IMS Market Analysis , Nov 2015 est.
  • 10. New Measures will further limit access to innovation and investment in Greece A similar new product rebate (1/3 the size) in Cyprus led to 20 products not being launched and the eventual removal of the rebate Innovation Forum Greece Area Measure Implication Reimbursement Criteria 14 Countries/7 HTA Double or triple the time to launch a product in Greece New Product Rebate 25% Will Likely prevent most products from launching in Greece Structural Reform None Will ensure rebates/claw backs remain high and in so doing threaten existing investment Re-pricing Maintain price protection for Generics Ensure that there continues to be limited room for innovation
  • 11. Greece already ranks low in innovation - what’s the right direction for the future? Innovation Forum Greece
  • 12. What we can do to maintain and increase investment in Greece  Immediate Removal of new measures which harm innovation and limit Foreign Investment  A transparent evidence based P&R system that recognizes and rewards innovation  A public pharma budget adequate enough to cover patient’s real needs  Appropriate investment incentives  Allow clinical trials to be offset against the clawback  Tax incentives  Collaborative effort to improve the time required to approve a clinical trial  Development of a national multi-year plan for pharmaceuticals to contribute to the economic growth of Greece done via a public-private partnership Innovation Forum Greece